UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011085 |
|---|---|
| Receipt number | R000012976 |
| Scientific Title | Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2016/02/01 13:56:52 |
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Basic information
Public title
Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study
Acronym
Influence of MRP4 on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide
Scientific Title
Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study
Scientific Title:Acronym
Influence of MRP4 on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the effects of MRP4 genotype on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide by clinical trials in Japanese healthy volunteers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between MRP4 genotype and the changes of serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide
Key secondary outcomes
Change of serum electrolytes, cholesterol, triglycerides, pulse rate and blood pressure
Ratio of side effects by trichlormethiazide
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of trichlormethiazide 4 mg/day for 14 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese healthy volunteers who are 20 years or older and younger than 50
Key exclusion criteria
1.Disease that should be treated
2. On medical treatment
3. Hepatic dysfunction(AST>40 IU/L or ALT>40 IU/L)
4. Renal dysfunction (serum creatinine level>1.2 mg/dL)
5. History of cardiovascular disease
6. Serum uric acid level >7.5 mg/dL
7. Abnormal electrolytes values (Na or K)
8. Hematocrit >55 %
9. Allergy reaction to thiazide and its related diuretics
10. Woman who is pregnant or breastfeeding
11. Systolic blood pressure <90 mmHg or >140 mmHg (sitting position)
12. Body weight <40 kg or >90 kg
13. Not appropriate to this study by other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sasaguri Toshiyuki |
Organization
Faculty fo Medical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL
092-642-6082
sasaguri@clipharm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshihara |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-6082
Homepage URL
tatsuya@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology, Fuculty of Medicical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012976
